Trial Outcomes & Findings for Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer (NCT NCT01273805)
NCT ID: NCT01273805
Last Updated: 2017-06-14
Results Overview
2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and at the first restaging at 2 months.
Results posted on
2017-06-14
Participant Flow
20 participants were enrolled between January 2011 and October 2012.
Participant milestones
| Measure |
Hydroxychloroquine 400 mg b.i.d.
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Hydroxychloroquine 400 mg b.i.d.
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Overall Study
Radiologic PD or Symptom Deterioration
|
10
|
10
|
Baseline Characteristics
Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
66 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
ECOG Performance Status (PS)
PS0
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
ECOG Performance Status (PS)
PS1
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
ECOG Performance Status (PS)
PS2
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Site of Primary Tumor
Head or Head and Body
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Site of Primary Tumor
Body or Tail
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Location of Metastasis
Liver
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Location of Metastasis
Lung
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Location of Metastasis
Peritoneum
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Location of Metastasis
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and at the first restaging at 2 months.Population: The analysis dataset is comprised of all enrolled patients.
2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
2-month Progression-Free Survival Rate
|
10 percentage of patients
Interval 0.28 to 44.5
|
10 percentage of patients
Interval 0.28 to 44.5
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.Population: Biochemical response could not be estimated due to insufficient longitudinal CA 19-9 measurements. This was directly related to the observed lack of activity of the study drug and corresponding short duration of therapy.
Biochemical response rate was defined as the percentage of patients achieving on treatment a decrease in serum CA 19-9 by \> 30% from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.Population: The analysis dataset is comprised of all enrolled patients.
Tumor response rate is the percentage of patients achieving complete or partial response on treatment based on RECIST 1.0 criteria. For target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR for the evaluation of non-target lesions is the disappearance of non-target lesions and normalization of tumor marker level. Appearance of one or more new lesions is classified as progression of non-target lesions. CR or PR confirmation is required \>/= 4 weeks.
Outcome measures
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Tumor Response Rate
|
0 percentage of patients
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).Population: The analysis dataset is comprised of all enrolled patients.
Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Overall Survival
|
51.5 days
Interval 24.0 to 275.0
|
83 days
Interval 40.0 to 178.0
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).Population: The analysis dataset is comprised of all enrolled patients.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to time of objective progression on CT scan or the time of death for patients with clinical deterioration resulting in withdrawal from the trial. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients without an event were censored at date of last disease evaluation.
Outcome measures
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Progression-Free Survival
|
51.5 days
Interval 16.0 to 66.0
|
44.5 days
Interval 33.0 to 74.0
|
SECONDARY outcome
Timeframe: Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.Population: The analysis dataset is comprised of all treated patients.
All grade 4-5 adverse events with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms.
Outcome measures
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 Participants
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 Participants
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Grade 4-5 Treatment-Related Toxicity
|
0 Participants
|
0 Participants
|
Adverse Events
Hydroxychloroquine 400 mg b.i.d.
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Hydroxychloroquine 600 mg b.i.d.
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 participants at risk
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 participants at risk
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Investigations
Elevated alanine aminotransferase
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
lymphopenia
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
Other adverse events
| Measure |
Hydroxychloroquine 400 mg b.i.d.
n=10 participants at risk
Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
Hydroxychloroquine 600 mg b.i.d.
n=10 participants at risk
Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
20.0%
2/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Eye disorders
Blurred vision
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
50.0%
5/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
Elevated alanine aminotransferase
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
Elevated alkaline phosphatase
|
30.0%
3/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
Elevated aspartate aminotransferase
|
30.0%
3/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
General disorders
Facial edema
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
General disorders
Fatigue
|
30.0%
3/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
Hyperbilirubinemia
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Investigations
Leukopenia
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
50.0%
5/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash, maculo-papular
|
10.0%
1/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
|
40.0%
4/10 • Adverse events (AE) were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.
Maximum grade toxicity by type for a patient over time including only treatment-related events (possible, probable or definite attribution) was first calculated with patients therefore appearing once for a given type of toxicity. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place